Maquet Volista OR Light Systems Recalled for Fall Hazard
Getinge is recalling Maquet Volista OR light systems that may fall during use in operating rooms. Approximately 236,793 units are affected nationwide and globally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a risk-of-harm product (light system may fall in operating room). No illnesses or injuries have been reported. This hazard poses potential for injury but has not yet resulted in reported injury, placing it at Score 3 per the rubric.
Plain-English summary
Getinge Usa Sales Inc is recalling Maquet Volista operating room light systems, which include the Volista, Volista Access, Volista Access II, and Volista Standop models. Approximately 236,793 units of the affected light systems have been distributed.
The light systems are recalled due to a potential for the light system to fall in the operating room during use.
The affected systems have been distributed nationwide in the United States and globally to operating room facilities.
Facilities currently using these light systems should contact Getinge Usa Sales Inc for instructions on remediation. The FDA is monitoring this recall situation.
The recalled product
- Product
- Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, RO
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 236,793
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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